Robotic systems for assisting in a number of medical procedures have been proposed and implemented including neurosurgical, laparoscopic, and orthopedic procedures.
Computers are increasingly used to plan such complex surgeries by analyzing preoperative medical images such as Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scans of a patient. In order to execute the surgical plan, it is important to accurately align or register the three-dimensional (3D) preoperative data to an actual location of the anatomical features of interest during surgery. Further, when performing robotically assisted surgery, (for example, total hip replacement—when cutting a cavity into a patient's femur bone for the insertion of an artificial hip joint therein), it is very important to ensure anatomically critical regions are monitored with sufficient attention.
There may be a hazard when a medical device operates on a human with indirect surgeon's control. For example, during computer-controlled surgical operations with active surgical devices, the surgeon's monitoring of the operative site is required to ensure safety and efficacy. There may further be a hazard when the operator (synonymously a user or surgeon) is not aware of undesirable cutting performed by the surgical device if the area of cutting is obscured from the user or the user's attention is diverted. This hazard can potentially cause harm to the patient if a warning is not present and corrections are not made.
It is also important to consider the operator's freedom of movement during the procedure. For example, an operator that is required to actively engage with the medical device as it is operating can easily become fatigued.
Accordingly, in order to mitigate this hazard it has been desirable to attempt to determine anatomically critical regions that should be monitored during a computer-controlled surgical procedure and alert the operator during the surgery in situ. An operator controller can be added to the surgical device as a vigilance control which requires the surgeon to acknowledge the alert for active cutting to continue.
The ORTHODOC presurgical planning workstation and the ROBODOC robotic surgical system are described in a number of references, including the following: (1) Kazanzides, P., Zuhars, J., Mittelstadt, B. D., Taylor, R. H.: “Force Sensing and Control for a Surgical Robot,” Proc. IEEE Conference. on Robotics & Automation, Pages 612-616, Nice, France, May 1992. (2) Kazanzides, P., Zuhars, J., Mittelstadt, B. D., Williamson, B., Cain, P., Smith, F., Rose, L., Mustis, B.: “Architecture of a Surgical Robot,” Proc. IEEE Conference. on Systems, Man, and Cybernetics, Chicago, Ill., Pages 1624-1629, October, 1992. (3) Paul, H. A., Bargar, W. L., Mittelstadt, B., Musits, B., Taylor, R. H., Kazanzides, P., Zuhars, J., Williamson, B., Hanson, W.: “Development of a Surgical Robot For Cementless Total Hip Arthroplasty,” Clinical Orthopaedics, Volume 285, Pages 57-66, December 1992. (4) Kazanzides, P., Mittelstadt, B. D., Zuhars, J., Cain, P., Paul, H. A., “Surgical and Industrial Robots: Comparison and Case Study,” Proc. International Robots and Vision Automation Conference, Pages 1019-1026, Detroit, Mich., April 1993. (5) Mittelstadt, B., Kazanzides, P., Zuhars, J., Williamson, B., Pettit, R., Cain, P., Kloth, D., Rose, L., Musits, B.: “Development of a surgical robot for cementless total hip replacement,” Robotica, Volume 11, Pages 553-560, 1993. (6) Mittelstadt B., Kazanzides, P., Zuhars, J., Cain, P., Williamson, B.: “Robotic surgery: Achieving predictable results in an unpredictable environment,” Proc. Sixth International Conference on Advanced Robotics, Pages 367-372, Tokyo, November, 1993. (7) Cain, P., Kazanzides, P., Zuhars, J., Mittelstadt, B., Paul, H.: “Safety Considerations in a Surgical Robot,” Biomedical Sciences Instrumentation, Volume 29, Pages 291-294, San Antonio, Tex., April 1993. (8) Mittelstadt, B. D., Kazanzides, P., Zuhars, J., Williamson, B., Cain, P., Smith, F. Bargar, W.: “The Evolution of A Surgical Robot From Prototype to Human Clinical Use,” in Proc. First International Symposium on Medical Robotics and Computer Assisted Surgery, Volume I, Pages 36-41, Pittsburgh, Pa., September 1994.
Other publications which describe image registration in robotic surgical and other procedures include the following: (9) Grimson, W. E. L., Lozano-Perez, T., Wells III, W. M., Ettinger, G. J., White, S. J., Kikinis, R.: “Automated Registration for Enhanced Reality Visualization in Surgery,” Proceedings of the First International Symposium on Medical Robotics and Computer Assisted Surgery, Volume I, Sessions I-III, Pages 82-89, Pittsburgh, Pa., Sep. 22-24, 1995. (10) Nolte, L. P., Zamorano, L. J., Jiang, Z., Wang, Q., Langlotz, F., Arm, E., Visarius, H.: “A Novel Approach to Computer Assisted Spine Surgery,” Proceedings of the First International Symposium on Medical Robotics and Computer Assisted Surgery, Volume II, Session IV, Pages 323-328, Pittsburgh, Pa., Sep. 22-24, 1994. (11) Lavallee, S., Sautot, P., Troccaz, J., Cinquin, P., Merloz, P.: “Computer Assisted Spine Surgery: a technique for accurate transpedicular screw fixation using CT data and a 3-D optical localizer,” Proceedings of the First International Symposium on Medical Robotics and Computer Assisted Surgery, Volume II, Session IV, Pages 315-321, Pittsburgh, Pa., Sep. 22-24, 1994. (12) Potamianos, P., Davies, B. L., Hibberd, R. D.: “Intra-Operative Imaging Guidance For Keyhole Surgery Methodology and Calibration,” Proceedings of the First International Symposium on Medical Robotics and Computer Assisted Surgery, Volume I, Sessions I-III, Pages 98-104, Pittsburgh, Pa., Sep. 22-24, 1994. (13) Simon, D. A., Hebert, M., Kanade, T.: “Techniques for Fast and Accurate Intra-Surgical Registration,” Proceedings of the First International Symposium on Medical Robotics and Computer Assisted Surgery, Volume I, Sessions I-III, Pages 90-97, Pittsburgh, Pa., Sep. 22-24, 1995. (14) Peria, O., Francois-Joubert, A., Lavallee, S., Champleboux, G., Cinquin, P., Grand, S.: “Accurate Registration of SPECT and MR brain images of patients suffering from epilepsy or tumor,” Proceedings of the First International Symposium on Medical Robotics and Computer Assisted Surgery, Volume II, Session IV, Pages 58-62, Pittsburgh, Pa., Sep. 22-24, 1995. (15) Lea, J. T., Watkins, D., Mills, A., Peshkin, M. A., Kienzle III, T. C., Stulberg, D. S.: “Registration and Immobilization for Robot-Assisted Orthopaedic Surgery,” Proceedings of the First International Symposium on Medical Robotics and Computer Assisted Surgery, Volume I, Sessions I-III, Pages 63-68, Pittsburgh, Pa., Sep. 22-24, 1995. (16) Ault, T., Siegel, M. W.: “Frameless Patient Registration Using Ultrasonic Imaging,” Proceedings of the First International Symposium on Medical Robotics and Computer Assisted Surgery, Volume I, Sessions I-III, Pages 74-81, Pittsburgh, Pa., Sep. 22-24, 1995. (17) Champleboux, G., Lavallee, S., Cinquin, P.: “An Optical Conformer for Radiotherapy Treatment Planning,” Proceedings of the First International Symposium on Medical Robotics and Computer Assisted Surgery, Volume I, Sessions I-III, Pages 69-73, Pittsburgh, Pa., Sep. 22-24, 1995.
Various systems for image registration using fiducial implants are also described in U.S. Pat. Nos. 4,991,579; 4,945,914; 5,094,241; 5,119,817; 5,097,839; 5,142,930; 5,211,164; 5,230,338; 5,222,499; and 5,397,329 to Allen.
A system and method for performing robotically assisted surgery is described in U.S. Pat. No. 5,086,401. Computer-assisted imaging and probe tracking systems are described in U.S. Pat. Nos. 5,383,454; 5,198,877; and WO 91/07726. U.S. Pat. No. 5,806,518 describes a method and system for transforming a bone image into a robotic coordinate system by aligning a robotic probe within the medullary canal of the femur. U.S. Pat. No. 6,033,415 describes a method and system for transforming a bone image into a robotic coordinate system based upon registering between the robotic coordinate system and the image data set 1) two positional coordinates axially spaced apart along the bone and 2) a directional vector passing through at least one of the positional coordinates. Unfortunately, the ability to warn an operator of unintended movement of a surgical robot into critical areas of subject tissue has not been addressed adequately in the prior art.
Thus, there is a need for an improved system and method for monitoring a computer-assisted surgical procedure having critical regions during the procedure. There also exists a need to provide an efficient interface for a user receiving an alert of robotic movement into a critical area.